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Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile (DPP)

Primary Purpose

Postnatal Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multi-component intervention
Usual care
Sponsored by
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Depression focused on measuring postnatal depression, primary care, depressed women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Mothers meeting criteria for current DSM-IV major depression were eligible.

Exclusion Criteria:

  • who had received any form of treatment for their depression during their current postnatal period,
  • those who were pregnant,
  • with psychotic symptoms,
  • serious suicidal risk,
  • history of mania,
  • alcohol or drug abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PND-MCI

    usual care

    Arm Description

    The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed

    'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment

    Outcomes

    Primary Outcome Measures

    EPDS

    Secondary Outcome Measures

    four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.

    Full Information

    First Posted
    August 20, 2007
    Last Updated
    August 20, 2007
    Sponsor
    Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00518830
    Brief Title
    Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile
    Acronym
    DPP
    Official Title
    Randomized Clinical Trial for the Treatment of Postnatal Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.
    Detailed Description
    Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile. Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postnatal Depression
    Keywords
    postnatal depression, primary care, depressed women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    230 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PND-MCI
    Arm Type
    Experimental
    Arm Description
    The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed
    Arm Title
    usual care
    Arm Type
    Active Comparator
    Arm Description
    'Usual care' included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
    Intervention Type
    Other
    Intervention Name(s)
    multi-component intervention
    Intervention Description
    The PND-MCI included psycho-educational groups, structured pharmacotherapy if needed, and systematic monitoring of clinical progress and treatment compliance
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    included all services normally available in the clinics, including antidepressant medication, brief psychotherapeutic interventions or referral for specialty treatment
    Primary Outcome Measure Information:
    Title
    EPDS
    Time Frame
    3 and 6 months
    Secondary Outcome Measure Information:
    Title
    four dimensions of the Short Form-36 (SF-36) Questionnaire: mental health; emotional role; social functioning; and vitality(34) and significant clinical improvement.
    Time Frame
    3 and 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mothers meeting criteria for current DSM-IV major depression were eligible. Exclusion Criteria: who had received any form of treatment for their depression during their current postnatal period, those who were pregnant, with psychotic symptoms, serious suicidal risk, history of mania, alcohol or drug abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Graciela Rojas, MD
    Organizational Affiliation
    University of Chile
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17993363
    Citation
    Rojas G, Fritsch R, Solis J, Jadresic E, Castillo C, Gonzalez M, Guajardo V, Lewis G, Peters TJ, Araya R. Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial. Lancet. 2007 Nov 10;370(9599):1629-37. doi: 10.1016/S0140-6736(07)61685-7.
    Results Reference
    derived

    Learn more about this trial

    Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile

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